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Pentoxifylline for Cocaine Use Disorder

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What is being tested

Placebo

+ Cocaine (IV)
+ Pentoxifylline
Drug
Who is being recruted

Methamphetamine Use Disorder

From 18 to 55 Years
+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Placebo-Controlled
Early Phase 1
Interventional
Study Start: November 2025

See protocol details

Summary

Principal SponsorWilliam Stoops
Study ContactWilliam W Stoops, PhD
Last updated: September 19, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2025Actual date on which the first participant was enrolled.

This study aims to explore how a medication called pentoxifylline might affect people who use cocaine. Cocaine use disorder is a condition where individuals struggle to control their cocaine use, leading to various health and social problems. Researchers are interested in understanding if pentoxifylline, which is known to target inflammation in the body, can alter the effects of cocaine. This could potentially lead to new ways to help those with cocaine use disorder by reducing harmful effects or cravings associated with cocaine use. Participants in this study will receive pentoxifylline and then be observed in a controlled environment to see how it influences their response to cocaine. This involves monitoring various aspects, such as the body's reaction and any changes in behavior or cravings. By examining these responses, researchers hope to gather valuable data on the interaction between pentoxifylline and cocaine, paving the way for future treatments. The study is conducted carefully to ensure participants' safety while collecting essential information.

Official TitleTargeting Immune Inflammation in Cocaine Use Disorder: A Human Laboratory Study With Pentoxifylline 
Principal SponsorWilliam Stoops
Study ContactWilliam W Stoops, PhD
Last updated: September 19, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
30 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Basic Science Study
Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 55 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Methamphetamine Use Disorder
Criteria
7 inclusion criteria required to participate
ECG, read by a cardiologist, within normal limits,
recent smoked or intravenous cocaine use verified by benzoylecgonine positive urine, as well as fulfillment of DSM-5 diagnostic criteria for CUD,
able to speak/read English,
female or male between the ages of 18 and 55 years,

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9 exclusion criteria prevent from participating
judged to be medically or psychiatrically unhealthy by study physicians at the time of screening,
under 18 years or over 55 years,
ECG, read by a cardiologist, outside normal limits,
no recent smoked or intravenous cocaine use as indicated by benzoylecgonine negative urine and no DSM-5 diagnosis of CUD,

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

33.333% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Placebo
Subjects will be treated daily with an oral placebo.
Group II
Experimental
Subjects will be treated daily with oral pentoxifylline (1200 mg).
Group III
Experimental
Subjects will be treated daily with oral pentoxifylline (1600 mg).
Study Objectives
Primary Objectives

Number of Times Subjects Choose Methamphetamine (Maximum of 5 Choices) Over Money

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Psychopharmacology of Addiction LaboratoryLexington, United StatesSee the location
Recruiting soonOne Study Center